MAY 2001

 

WEEK ENDING MAY 11

 

PRODUCT: Keftab (Cephalexin Hydrochloride)  500mg.  NDC 5147-9034-02, 6445-034-02, 64455-034-01 and 64455-034-10.  Keftab tablets are sold in bottles of 100 and 60 count blisters. 

CODE:

Lot #                       Expiration date

3AP73A                                 10/1/01

3AR48A                                 1/1/02

3AS36A                                 2/1/02

3AS37A                                 8/1/02

3AD93A                                4/1/01

3AD94A                                4/1/01

3AD96B                                 4/1/01

3AE63B                                  4/1/01

3AG03A                                 5/1/01

3AG38A                                 4/1/01

3AG40A                                 10/1/00

3AG73A                                 5/1/01

3AH64A                                 8/1/01

3AH65A                                2/1/01

3AM54A                               10/1/01

3AM55A                               10/1/01

3AP74A                                 10/1/01

3AR46A                                 12/1/01

3AR47A                                 6/1/01

3AR49A                                 1/1/02

3AR50A                                 1/1/02

3AS34A                                 2/1/02

3AS35A                                 2/1/02

3AS36A                                 2/1/02

3AS37A                                 2/1/02

3AS38A                                 2/1/02

3AS39B                                  8/1/01

4AA77A                                2/1/02

4AA78A                                8/1/02

4AD08A                                5/1/02

4AD09A                                11/101

4AD10M                                12/1/01

4AE21A                                 6/1/02

4AE22A                                 12/1/01

4AE23M                                1/1/02

4AE24M                                2/1/02

4AE25B                                  2/1/02

4AE26B                                  8/1/02

4AF21D                                 8/1/02

4AF22A                                 8/1/02

4AF23A                                 8/1/02

4AF24A                                 8/1/02

4AG82A                                 3/1/02

4AG83D                                 9/1/02

4AG84M                                3/1/02

4AK36C                                 3/1/02

4AK37A                                9/1/02

4AK38B                                 9/1/02

4AK39A                                9/1/02

4AK40A                                10/1/02

4AK41B                                 10/1/02

4AK42B                                 4/1/02

4AK44C                                 4/1/02

4AL40A                                 8/1/02

4AM60A                               9/1/02

4AN34B                                 11/1/02

4AN35A                                11/1/02

MANUFACTURER: Lilly del Caribe, Carolina, PR.

RECALLED BY: Eli Lilly and CO., Indianapolis, IN

DISTRIBUTION: Nationwide.

QUANTITY: 45,189,243 units.

REASON: Problems with dissolution properties.

 

PRODUCT: P.G. Walker Compressed Oxygen USP in M-6 aluminum cylinders with a Sherwood valve

CODES: Lot 513-1710-37.

MANUFACTURER: P. G. Walker, Div. of Air Products and Chemicals Joplin, MO.

RECALLED BY: Lincare, Inc.

DISTRIBUTION: Southwest Missouri.

QUANTITY: 23 cylinders.

REASON: Strong chlorine odor emitted from the oxygen cylinder.

 

PRODUCT: Tetrahydrozine HCI Nasal Spray 0.1% and Pediatric Nasal Drops 0.05%. Brand name-Tyzine.  Both 15 ml (1/2 Fl oz) units

CODE: 0.1% -- Lot 6234 exp.8/2002; 0.05% -- lot 6235 exp. 8/2004.

MANUFACTURER: Denison Pharmaceuticals,  Inc., Pawtucket, RI.

RECALLED BY: Kenwood Therapeutics

DISTRIBUTION: Nationwide.

QUANTITY: Lot 6235--25,397 units; Lot 6234 -- 11,595 units.

REASON: High counts of microbiological contamination. 

 

PRODUCT: Heart-Trex Tablets

CODE: a) Safety Pack Boxes (250 Packets of 2); b)  C577 Unit boxes of 8X2 Packets All lots.

MANUFACTURER: Otis Clapp & Son, Inc., Canton, MA.

DISTRIBUTION: AL,FL,GA,IN,KY,MA,NC,NJ,NY,NV,OH,OR,PA,TN,TX,WA

QUANTITY: Safety Pack: 320 boxes  C577 Units: 297 boxes.

REASON: Product distributed without an approved new drug application for the cardiovascular related uses represented in the labeling and because it bears no dosage direction for use in pain and fever relief.

 

PRODUCT: Armour Thyroid (thyroid tablets, USP) 2 Grain (120 mg), each tablet provides 76 mcg levothyroxine (T4) and 18 mcg liothyronine (T3), 100 tablets, (10) 2x5 unit dose strips, individually blister-sealed tablets, RX indicated as a replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transiet hypothyroidism during the recover phase of subacute thyroiditis.  

CODE: Lot 30012, Exp.12/01.

MANUFACTURER: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. 

DISTRIBUTION: Nationwide.

QUANTITY: 553/10/10 tablet strip boxes.

REASON: The incorrect NDC number is printed on the blister cards.

 

PRODUCT: Cimetidine Tablets, USP, 800 mg. In bottles of 100 tablets

CODE: Lot 90570A and Lot 00197A.

MANUFACTURER: TorPharm, A Division of Apotex, Etobiocoke, Ontario, Canada.

DISTRIBUTION: FL, MI, CA, IN, TN, NY, IL, TX, WI, MN and KY.

QUANTITY: 2013 bottles of 100 tablets.

REASON: Lot 90570A failed the 12 month test station dissolution test at room temperature conditions. Lot 00197A went to S3 testing during followup testing of 35 lots of the same age range. 

 

PRODUCT: Pin-Rid Soft Gel Capsules, Each Capsules contains 180 Mg Pyrantel.

CODE: Lot 5085H.

MANUFACTURER: Apothecary products, Inc., Burnsville, MN.

DISTRIBUTION: AK, CA, FL, IL, MN, NJ, OH, OK, OR, TX.

QUANTITY: 600 bottles.

REASON: All the bottles in the recalled lot each contained 12 instead of 24 capsules as labeled.

 

WEEK ENDING MAY 18

 

PRODUCT: Goldline brand of Genaton Antacid 12 fl. oz. Bottle

CODE: Lot #s: 01011 and 01012.

MANUFACTURER: RIJ Pharmaceutical Corp. Middletown, NY.

DISTRIBUTION: Nationwide.

QUANTITY: 12,899 bottles.

REASON: Product odor and discoloration.

 

PRODUCT: Children's Mylanta Upset Stomach Relief (Calcium Carbonate Antacid), 5 oz liquid bottles.  The product is shipped 12 bottles per shipper. 

CODE: DCF 033 exp. 2/02, DCF 060 exp. 3/02, DEF 044 exp. 4/02, DEF 134 exp. 4/02, DEF 047 exp. 5/02, DHF 023 exp. 6/02, DJF 066 exp. 7/02, DJF 118 exp. 7/02, DJF 123 exp. 7/02, DPF 042 exp. 10/02, DSF 032 exp. 11/02, EAF 011 exp. 12/02, EBF 049 exp. 1/03 and EBF 071 exp. 1/03.

MANUFACTURER: Johnson & Johnson Merck Consumer Pharmaceuticals Company, Fort Washington, PA.

DISTRIBUTION: Nationwide and PR. Firm-initiated recall ongoing.

QUANTITY: 770,000 bottles.

REASON: Failure to perfrom icrobiological testing as per USP antimicrobial effectiveness test method.

 

PRODUCT: Methocarbamol Tablets,USP, 750 mg, 100 count, Rx only

CODE: Lot 73013340, EXP Date 11/2001. Skeletal Muscle Relaxant

MANUFACTURER: Watson Laboratories Corona, CA.

DISTRIBUTION: TX, MO, MN, MS, OH, FL, NY, NC.

QUANTITY: 7065 bottles.

REASON: Product may contain metal fragments.

 

PRODUCT: a) Oxygen, USP, compressed, in Aluminum Cylinders; b) Nitrogen, NF, compressed, steel tanks sizes H and E. 

CODE: a) Aluminum Oxygen Tank lot numbers: 0990J001-04, 0992J006-04, 0993J007-02, 0993J007-04, 0994J011-01, 0994J013-01, -02, -03, 0994J014-01, -03, 0995J015-01, -03, 0995J019-05, -08, 0995J020-03, 04, -05, 0997J021-03, 0997022-01, -02, -03, -04, 0997J025-05, -06, 0997J026-03, -04, 0997J027-02, -06, -07, 0998J029-02, -03, 0998J028-02, -03, -04, 0990K002-01, -02, 0992K003-02, -03, 0993K003-01, 0993K005-02, -03, 0993K005-01, -08, 0997K012-02, 0998K016-03, 0998K016-06, 0999K017-01, -02, 0999K018-01, 0999K019-03, -05, 0990K020-01, -02, 0992K023-01, 0992H906-07, 0992H909-01, 0994H909-03, 0994H910-01, -02, -04, 09995H911-02, -03, 0997H917-01, -02, -03, 0997H918-03, 0997H919-01, -02, -03, 0997H920-01, -02, -03, 0998H923-04, 0998H923-01, -02, -03, 0998H924-01,0999H925-01, -02, -03, 0999H925-05, 0999H927-04, 0999H926-01, -03, 0999H927-01, -02, -03, 09910H930-05, -08, -09, -10, 09910931-01, -02, -03, 09910J931-05, -05, -06.

b) Steel Tank Nitrogen NF lot numbers: 0990K002-01, 0990K002-02, 0990K003-01, 0991K006-01, 0991K006-02, 0991K006-03, 0991K006-04,

0991K009-01, 0991K009-02, 0991K012-01, 0993K013-01, 0993K013-02, 0993K013-03, 0993K016-01, 0993K018-01, 0993K018-02, 0993K019-01,

0994K020-01,  0994K020-02, 0994K023-01, 0994K023-02, 0995K026-01, 0996K030-01, 0996K030-02.

MANUFACTURER: Holox, Ltd., Norcross, GA

DISTRIBUTION: FL and GA.

QUANTITY: 97 Oxygen cylinders and 24 Nitrogen NF cyclinders.

REASON: a) Oxygen cylinders may be overfilled. b) Nitrogen cylinders for possible C02 contamination.

 

PRODUCT: Trimox 250 mg/5 mL - 150 mL (Amoxicillin for Oral Suspension, USP), NDC 0003-1738-45, HDPE bottle (200 mL) with child resistance cap. Rx only. ANDA-61-886

CODE: OC31128, OC31131, OC31133, OD23895, OD23899, OD23901, OD23903, OD23914, OD23919, OD23925, OD23930, OD23943,

OD23945, OD23948, OD23950, OD23951, OD23952, OD23954, OD23955, OD23959, OD23967, OD23968, OD23969, OD23971,

OD23983, OD23986, OD27582, OD27587, OD27592, OD27602, OD27607, OD27619, OD27626, OD27723, OD27727, OD27750

Exp. Date for all lots is October 2002

MANUFACTURER: Apothecon, A Bristol-Myers Squibb Company, Plainsboro, NJ.

DISTRIBUTION: Nationwide.

QUANTITY: 831, 267 bottles.

REASON: Microbial contamination (mold).

 

PRODUCT: Finast Acne Wash, Acne Treatment with Salicylic Acid, containing 23.0% salicylic acid, packaged in 6-fl. Oz.containers, 12 per case, OTC. 

CODE: Lot 0H01B, Exp.08/02.

MANUFACTURER: Qualis, Inc. Des Moines, IA.

DISTRIBUTION: New York.

QUANTITY: 2,592 contianers.

REASON: Component defect:  Stainless steel sping within pump assembly is discoloring.

 

PRODUCT: FRESH-N-CLEAN Hand Washing and Sanitizing Compound, packaged in one (1) gallon containers, 4 containers per case.  The active ingredient is: Didecyldimethylammonium Chloride (trade name: BARDAC 2250). 

CODE: Case codes: 050697, 090397, 082698, 0824991, and 1116991.

MANUFACTURER: Steiner Company, Inc. Holland, OH.

DISTRIBUTION: Ohio.

QUANTITY: 768 cases.

REASON: The product contains C.I. Acid Blue #80; C.I. 61585 (trade name: Sandolin Milling Blue N-BLA Powder 150), which is an unapproved dye.

 

PRODUCT: ANTI-MICROBIAL HAND SOAP, packed in 800 ml bags (inside a box), for use in the ìBag-In-Boxî dispensers, 12 per case.  This is an OTC drug product; the active ingredient is parachlorometaxylenol (PCMX). 

CODE: C022161, C021371, C040371, C050571, C062672, C071971, C112271, C011381, C041381, C071781, C121581, C021691, C030391, C052591, C071391, C072991, C082691, C090891, C110391, C121591, C031401, C040501, C060101, C071001, C091401, and C110801.

MANUFACTURER: Steiner Company, Inc. Holland, OH.

DISTRIBUTION: Illinois.

QUANTITY: 6,899 cases.

REASON: The product contains C.I. Acid Yellow #36 (trade name: Metanil Yellow), which is an unapproved dye.

 

PRODUCT: a) Crinone 4%,(progesterone gel) [6/PACK] ; b) Crinone 8% (Progesterone gel) [18/Pack] [6/Pack]

CODES:a) Lot Number: C0118, Expiration 10/2002;

b) Lot Numbers:   C00103  Expiration 02/2002

                                C00104                   03/2002

                                C00107                   04/2002

                                C00109                   06/2002

                                C00113                   08/2002

                                C00114                   08/2002

                                C00115                   09/2002

                                C00116                   09/2002

                                C00119                   10/2002

                                C00122                   11/2003

Distributed by Serono Laboratories Randolph, MA. 

NDA 20-701; NDA 20-756

MANUFACTURER: Fleet Laboratories, Watford, England

RECALLED BY: COLUMBIA RESEARCH LABORATORIES, INC. NY. Serono Inc., Norwell, MA

DISTRIBUTION: Nationwide.

QUANTITY: 4%=10,622 units 6%=107,674.

REASON: Failure to meet the specifications for viscosity.

 

WEEK ENDING MAY 25

 

PRODUCT: Discount Drug Mart Food Fair brand Stool Softener (OTC) Docusate Sodium, 100 mg, 100 capsules (softgels) bottles

CODE: Lot J043, expiration date 12/2001.

MANUFACTURER: PL Developments, Farmingdale, NY.

RECALLED BY: PL Developments

DISTRIBUTION: OHIO

QUANTITY: 1440 units were distributed to the Own Label Distributor. Firm estimates that approximately 562 bottles remain in commerce.

REASON: Mispackaging; Bottles of Stimulant Laxative Plus Stool Softener (Casanthranol and Docusate Sodium ) were erroneously packaged into unit cartons labeled only as a Stool Softener (Docusate Sodium).

 

PRODUCT: a) Oxygen, U.S.P., high pressure cylinders,various sizes; b) Oxygen, USP, liquid, in HLD's. 

CODES:

Lot Number                                        Cylinder Sizes

536-3059-80 0102                               K, M, Q, T

536-3149-82 0101                               K, M, Q

536-3239-85 0102                               K, M

536-3349-87 0102                               K

536-3369-88 0102                               K, M, T

536-3419-88 0102                               K

536-3429-89 0102                               K, M, T

536-3549-91 0101                               E, K, M, Q

536-3569-91 0102                               K, M, Q

536-3629-93 0101                               K

536-0880-19 0603                               B, D, E

536-0880-19 0604                               E

536-1390-30 0101                               K, M, Q

536-2300-48 01                  190 liters-HLD

536-2500-51 01                  190 liters-HLD

536-2520-52 01                  160 liters

MANUFACTURER: P.G. Walker, 1405 Walnut St, Springfield, MO. 65806

RECALLED BY: P.G. Walker

DISTRIBUTION: MO, OK, TN, AR, KS, TX, and IN.

QUANTITY: The firm distributed 587 cylinders of varying sizes

REASON: Current good manufacturing practice (CGMP) deviations, including but not limited to finished products assays missing from production records.

 

PRODUCT: a) Geneva Tretinoin Gel, USP, 0.025%, Batch #PMIP NET WT. 15 G

b) Geneva Tretinoin Gel, USP, 0.025%, Batch #PMIP-1 NEW WT. 45 G

CODE:  (15 gm) Batch # PMIP, Exp 11/02;  (45 gm) Batch # PMIP-1, Exp 11/02.

MANUFACTURER: DPT LABORATORIES, SAN ANTONIO,TX.

RECALLED BY: SPEAR PHARMACEUTICALS, TITUSVILLE, FL

DISTRIBUTION: Nationwide.

QUANTITY: 12,336 bottles of 15gm; 15,852 bottles of 45gm.

REASON: VISCOSITY FAILURE, (3 MONTH STABILITY STATION).

 

PRODUCT: Children's Mylanta Upset Stomach Relief (Calcium Carbonate Antacid), 5 oz liquid bottles. The product is shipped 12 bottles per shipper. 

CODE: DCF 033 exp. 2/02, DCF 060 exp. 3/02, DEF 044 exp. 4/02, DEF 134 exp. 4/02, DEF 047 exp. 5/02, DHF 023 exp. 6/02, DJF 066 exp. 7/02, DJF 118 exp. 7/02, DJF 123 exp. 7/02, DPF 042 exp. 10/02, DSF 032 exp. 11/02, EAF 011 exp. 12/02, EBF 049 exp. 1/03 and EBF 071 exp. 1/03.

MANUFACTURER: Johnson & Johnson Merck Consumer Pharmaceuticals Company, Lancaster,PA.

RECALLED BY: Johnson & Johnson Merck Consumer Pharmaceuticals Company, Fort Washington, PA

DISTRIBUTION: Nationwide

QUANTITY: 770,000 bottles.

REASON: FAILURE TO PERFORM MICROBIOLOGICAL TESTING AS PER THE USP ANTIMICROBIAL EFFECTIVENESS TEST METHOD.